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TerminatedNCT01105962NBIRR-1Updated Sep 20, 2016

Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder

An observational study in Traumatic Brain Injury and Post-traumatic Stress Disorder, sponsored by International Hyperbaric Medical Foundation. Terminated at 10 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-20.

Sponsored by International Hyperbaric Medical Foundation · Observational

Why this study was terminated
new regulatory requirements will require funding for restart as a new study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
133
Ages
18 Years to 65 Years
Sex
All
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Study summary

This is an observational research study whose purposes are to see:

  1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
  2. if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health.
  3. determine the long-term outcome of the treatment.
  4. confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies
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Conditions studied

  • Traumatic Brain Injury
  • Post-traumatic Stress Disorder

Keywords

  • traumatic
  • brain
  • injury
  • post-traumatic
  • stress
  • hyperbaric
  • oxygen
  • HBOT
  • TBI
  • PTSD
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 133 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

This is the only study on the registry with International Hyperbaric Medical Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

One thousand subjects will be recruited. Subjects will be 18-65 years old and have been diagnosed with mild or moderate (but not severe) TBI or TBI/PTSD or PTSD by either the military (any etiology) or civilian neurologists or neuropsychologists. This diagnosis will especially include war veterans who have had a significant decrease in their neuropsychological test scores.

There will be no gender restriction. However, it is anticipated that the cohort will consist mostly of males, due to the nature of the injury. There will be no race or ethnicity restriction.

All subjects will be legally capable of consenting. No subjects who need 3rd party consent will be enrolled in the NBIRR study.

Military - Unless specifically approved by a military site IRB, active duty participants will have to voluntarily contact NBIRR participating sites or respond to a recruitment outreach outside of the command.

Inclusion criteria

  1. Any 18-65 year-old patient with mild-moderate TBI or PTSD. (If a military injury, subject may be active duty or a veteran. If active duty, participants will have to voluntarily contact NBIRR.)
  2. Have demonstrated a >20% decrement (compared to pre-deployment baseline) in ANAM composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time".
  3. Have a diagnosis of TBI, chronic TBI/PCS or TBI/PCS/PTSD or PTSD made by a military (military etiology of blast injury) or civilian specialist.
  4. Negative pregnancy test in females.
  5. Less than 90% on the Percent Back to Normal Rating Scale. (If patient is considered 100% normal before TBI, patient should be less than 90% normal for entry into the study).

Exclusion criteria

Exclusion Criteria:

  1. Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
  2. Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
  3. Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
  4. Pregnancy.
  5. Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
  6. Participation in another experimental trial with active intervention.
  7. High probability of inability to complete the experimental protocol (e.g. terminal condition).
  8. Past or current history of mental retardation unless diagnosed post TBI (baseline IQ ≤ 70).
  9. Pre- or post-TBI history of systemic illness with impact on central nervous system. (Principal Investigator in consultation with study sponsor Medical Officer will make the ultimate decision).
  10. Any pre-existing chronic infection not related to battlefield injuries or government service.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
133 participants (actual)
06

What researchers measure

Primary outcomes

  1. Cognitive Function

    Time frame: 2-6mo then every 6 months for 2yrs

07

Study locations

10 sites
  • San Francisco Institute for Hyperbaric Medicine
    San Francisco, California 94107, United States
  • Rocky Mountain Hyperbaric Institute
    Boulder, Colorado 80301, United States
  • Hyperbaric Services of the Palm Beaches
    Del Ray Beach, Florida 33484, United States
  • Hyperbaric Medicine Inc. of Florida
    Ft. Walton Beach, Florida 32547, United States
  • Idaho Wound Care & Hyperbaric Medicine
    Pocatello, Idaho 83201, United States
  • Lifeforce Therapies
    Plymouth, Minnesota 55447, United States
  • Hyperbaric Institute of Nevada and Clinical Neurology Specialists
    Henderson, Nevada 89012, United States
  • Alliance Community Hospital Wound Care and Hyperbaric Department
    Alliance, Ohio 44601, United States
  • HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia
    Reston, Virginia 20190, United States
  • Fox Valley Wellness Center
    Fond du Lac, Wisconsin 54935, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01105962
Lead sponsor
International Hyperbaric Medical Foundation
Responsible party
Sponsor
First posted
Apr 19, 2010
Start date
May 2010
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Sep 20, 2016

Study contacts

B Robert Mozayeni, MD
study director · International Hyperbaric Medical Foundation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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